BTEC 3317 Test 3
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135 Terms
What is the best definition of drugs according to the FDA?
Drugs are intended for use in the cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diversion, cure, mitigation, treatment, or prevention of disease in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
Drugs are intended for use in the diagnosis, cure, mitigation, treatment, or worsening of disease in man
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
3 multiple choice options
Which statement is incorrect about drugs regulated by FDA?
Non-prescription drugs are available over-the-counter and can be procured without the need for medical supervision
Prescription drugs are used under medical supervision of a healthcare practitioner.
Dietary supplements (herbs, vitamins) do not require FDA approval prior to marketing, as they are GRAS and regulated as food, not as drugs
Substances used for diagnosis of diseases are not considered as drugs
Substances used for diagnosis of diseases are not considered as drugs
3 multiple choice options
What does not apply to patent medicines?
Patent medicines are also known as snake oil, cure alls, or miracle elixirs
Medical benefits of patent medicines have not been proven to work for all diseases that they claim to treat
Salesmen of patent medicines claim that they cure many ailments from rheumatism and cancer to colicky babies
Patent medicines were sold through internet pharmacies
Patent medicines were sold through internet pharmacies
3 multiple choice options
The tetanus-contaminated diphtheria antitoxin that resulted to deaths of children in 1901 and that led to the passage of the Biologics Control Act of 1902 was produced from:
Bacterial cells grown in bioreactors
Mammalian cells grown in bioreactors
The blood serum of a horse
The milk of goats
The blood serum of a horse
3 multiple choice options
Dr. Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that particular clinical trial?
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
No informed consent forms describing possible bad effects on participants health were signed
There was no untreated control group for comparison against the group that was given the preservatives
The trial participants were volunteers, not prison inmates
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
3 multiple choice options
Harvey Wiley's "clinical trials" with the poison squad tested the toxic effects of food preservatives. Which of these still widely used preservative was not banned under the Pure Food and Drug Act of 1906 and still used today? For the long exam, you will need to know all preservatives which are still used today and those that are now banned,
Potassium nitrate
Salicylic acid and salicylates
Formaldehyde
Boric acid and borax
Potassium nitrate
3 multiple choice options
In legal usage, amendments refer to:
approval of a bill by the Congress and Senate
any additions or changes to parts of an existing law or bill
signing of a proposed law by the President of the United States
an offer of compensation to people harmed by an earlier law
any additions or changes to parts of an existing law or bill
3 multiple choice options
What does not have to do with the Federal Food Drugs and Cosmetic Act of 1938?
Toxic elixir formulation of a sulfanilamide antibiotic
A penicillin analog used in drug formulation
A requirement for physician's prescription before a patient can purchase certain drugs
Setting tolerances for cocaine, heroine, alcohol and morphine in drugs
A penicillin analog used in drug formulation
3 multiple choice options
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?
Requirement for safety and efficacy before drug marketing approval
Patent medicines with unknown ingredients
Required companies to notify the FDA before commencing testing of new drugs in human subjects
Thousands of babies born with deformed limbs in Europe to women who took Thalidomide
Patent medicines with unknown ingredients
3 multiple choice options
The death from Children's Tylenol laced with cyanide led to certain requirements for tamper-evident packaging. What is not part of tamper-evident packaging requirement for over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982?
Labels should clearly state that adult supervision is required for tampering.
Device should provide clear and visible evidence if tampering has occurred
Tamper-evident package should be distinctive by design
Tamper-evident device should be identified on label.
Labels should clearly state that adult supervision is required for tampering
3 multiple choice options
What is not true of the Hatch-Waxman Act of 1984?
Generic drugs can be marketed only if the patent of the pioneer drug had expired
Provided patent holders an extended term of protection from competition in the market place if there is delay in obtaining marketing approval
Large and expensive clinical trials, similar to that of branded drug trials, are required for marketing approval of the copycat drugs
Studies that show comparable bioavailability of the active ingredient in human subjects are required
Large and expensive clinical trials, similar to that of branded drug trials, are required for marketing approval of the copycat drugs
3 multiple choice options
What applies to the Prescription Drug Marketing Act of 1987?
The Act banned US manufacturers from reimporting prescription drugs that had already been exported to other countries.
The Act was legislated in response to a lack of enough effective drugs for AIDS
The Act arose from concerns about illegal sales of excess pharmacy inventories
The Act was passed to help accelerate the approval process for new drug applications
The Act arose from concerns about illegal sales of excess pharmacy inventories
3 multiple choice options
What was the FDA's response to the urgent need of patients for another effective drug against AIDS?
Allow the uncontrolled introduction of newly approved drugs across state borders
Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-approved for marketing
Allowed the marketing of less expensive generic copies of branded drugs to AIDS patients
Allowed the use in AIDS patients of candidate drugs without requiring safety and efficacy tests in humans
Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-approved for marketing
3 multiple choice options
The Prescription Drug Users Fee Act of 1992 was passed mainly to:
Force drug manufacturers to pay the FDA for their drug reviews
Educate consumers as to the proper use of drugs
Shorten the time for new drug review and marketing approval
Encourage the development of safer and more effective drugs
Shorten the time for new drug review and marketing approval
3 multiple choice options
The drug, Vioxx, a widely used drug indicated for arthritis, was withdrawn from the market after it was linked to:
Liver dysfunction
Heart problems
Suicidal thoughts in young people
Schizophrenia
Heart problems
3 multiple choice options
What is not true of biologics?
Biologics can be made up of more than 10,000 atoms
Biologics include any natural protein consisting of more than 40 amino acids
Biologics are not normally susceptible to microbial contamination
Chemical characterization of a biologics is not easily accomplished using analytical chemistry techniques
Biologics are not normally susceptible to microbial contamination
3 multiple choice options
Generic drugs have certain properties that should be the same as brand name drugs. What is not expected to be the same in a generic and in a branded drug?
Same dosage form
Same route of administration
Same label
Same active ingredient
Same label
3 multiple choice options
Drug product refers to a finished dosage form. What is not considered a dosage form? Can search for dosage forms at https://www.fda.gov/industry/structured-product-labeling-resources/dosage-forms.
Capsules
Active ingredient
Injectables
Elixir
Active ingredient
3 multiple choice options
What is not true of the inactive ingredients found in drug products?
Inactive ingredients are a common component of drug products
Inactive ingredients include starch binders in tablets
Inactive ingredients do not affect the efficacy properties of a drug product
Inactive ingredient is not the main drug component that is responsible for pharmacologic activity of a drug product
Inactive ingredients do not affect the efficacy properties of a drug product
3 multiple choice options
___________________ of a drug product is expressed as concentration of API (wt per vol, wt per wt, wt per tablet) or in activity units (IU or international units).
Formulation
Strength
Inactive ingredient
Therapeutic activity
Strength
3 multiple choice options
For drug delivery routes, certain types of APIs enter the body subcutaneously through the skin, while some goes through the tongue in which type of drug delivery?
Intrathecal
Oral
Sublingual
Intravenous
Sublingual
3 multiple choice options
What is true of biosimilars?
Clinical trials, with children as subjects, are required for marketing approval of biosimilars
An example of biosimilars would be store brand aspirin or ibuprofen
Animal and human clinical studies on safety and efficacy are still required of biosimilars
Biosimilars are significantly superior to the branded product in terms of safety and efficacy
Animal and human clinical studies on safety and efficacy are still required of biosimilars
3 multiple choice options
Orphan drugs are pharmaceutical and biological products that target diseases affecting under 200,000 patients in the US. What is not an incentive given to manufacturers to encourage the development of orphan drugs?
FDA waives PDUFA fee requirement
No other version of the drug will be approved during a twelve year market exclusivity
Subsidies for clinical research studies are provided by the FDA
FDA requires smaller patient numbers for clinical testing of the drug
No other version of the drug will be approved during a twelve year market exclusivity
3 multiple choice options
The FDA's Center for Biologics Evaluation and Research (CBER) handles marketing approval of many, but not all biologics. Which of these products are reviewed and regulated by CBER?
Antibodies, like those against SARS-2
Growth factors
Immunomodulators
Vaccines, like those for SARS-2
Vaccines, like those for SARS-2
3 multiple choice options
Which drug development department may be responsible for developing tests to quantify the ability of an antibody drug to bind to SARS-2 virus?
Business development group
Assay development group
Process development group
Clinical development group
Assay development group
3 multiple choice options
FDA defines a drug as any substance used for diagnosis, control, mitigation, prevention or treatment of disease. In drug regulation, the use of a drug for a particular disease or condition is referred to as its:
Active pharmaceutical ingredient
Prescription
Indication
Component
Indication
3 multiple choice options
Many biologics are manufactured using living cells. What is not a main concern of the process development group of a biologics manufacturer?
Developing clinical study protocols
Improving the purification process to optimize yield of the final formulated product
Monitoring the genetic stability or instability of the host cells
Optimizing product yield of the host cells in the bioreactor
Developing clinical study protocols
3 multiple choice options
What is not a good reason as to why there may remain a market for a new drug even if there is already an approved drug for a particular indication?
A new cancer drug that does not cause nausea will be preferred over an existing one that does
The new drug may be more effective than the currently administered drug against a newly discovered variant of a virus
For any given drug, more than 50% of patients with a condition may not respond to the existing drug
Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs
Two tablets that separately contain two different APIs will be preferred over one tablet that contains both APIs
3 multiple choice options
Johnson and Johnson picked Emergent Biosciences as CMO to manufacture the COVID vaccine for JNJ because JNJ didn't have spare facility, equipment, and personnel for large scale production of their vaccine. CMO stands for:
Commercialization management organization
Contract manufacturing organization
Consolidated manufacturing organization
Contract management organization
Contract manufacturing organization
3 multiple choice options
From the Roche video, what is the last step in the drug development process?
Generate tests and refine lead to come up with optimized chemical
Providing regulatory agencies with documentation to support marketing approval
Test safety and tolerability of candidate drug in human clinical studies
Conduct pre-clinical safety studies using cell cultures or animals
Providing regulatory agencies with documentation to support marketing approval
3 multiple choice options
According to the Roche video on target identification, there are several approaches to finding a candidate drug target. What is not one of Roche approach?
Comparing genes of healthy and diseased individuals to find the defective gene responsible for the disease
Using proteomics to Identify which proteins bind to or interact with an active drug
Phenotypic screening - Changing one gene at a time in cells of an organism and see whether the mutation leads to a disease state
Identifying what enzyme is involved in changing a drug to a less active chemical derivative
Identifying what enzyme is involved in changing a drug to a less active chemical derivative
3 multiple choice options
Roche video on target identification. Practically all medicine in use today interacts with a protein target by:
Either inhibiting or increasing the activity of a protein target
Neither inhibiting nor boosting the activity of the protein target
Increasing the activity of the protein target
Inhibiting the function of the protein target
Either inhibiting or increasing the activity of a protein target
3 multiple choice options
As part of in vitro, pre-clinical research, the Ames test is performed using bacteria to determine which property of a candidate drug?
The ability of a drug to kill test animals
The ability of a drug to produce DNA lesions
The ability of a drug to increase heart rate in trial animals
The ability of a drug to cause elevation of liver enzyme activity in mice
The ability of a drug to produce DNA lesions
3 multiple choice options
What applies to FDA's rules on pre-clinical testing of investigational drugs on animals?
Organs on chips are not acceptable alternatives to toxicity testing on animals
FDA's Modernization Act 2.0 of 2022 require that all investigational drugs need to be tested for safety on animals before they are tested on humans
Companies do not need FDA permission to initiate tests of drugs on animals even if the data will be used for marketing approval
With FDA's Modernization Act 2.0 of 2022, companies do not have the right to perform tests of investigational drugs on animals
Companies do not need FDA permission to initiate tests of drugs on animals even if the data will be used for marketing approval
3 multiple choice options
Choose the best answer. If required by FDA, in pre-clinical animal testing, the FDA would usually expect biologics to be tested in:
One mammal
Two small and two large mammals
One small mammal and one large mammal like a dog
One small mammal and a primate
One small mammal and a primate
3 multiple choice options
One type of pre-clinical research experiment is in vitro research. What does not apply to in vitro research?
Optimizing the chemical structure of a drug candidate to improve its safety profile
Determining changes in weights of rat organs
Determining in test tubes as to which human enzyme is inhibited by a candidate drug
Developing a colorimetric bioassay to assess ability of a drug to inhibit a protein's activity
Determining changes in weights of rat organs
3 multiple choice options
Which is not true of Good Laboratory Practices?
GLPs protect the integrity and quality of pre-clinical laboratory data submitted to the FDA
Started with deaths of test animals due to excessive bleeding from warfarin
Followed for any lab activity that will be used to support product submission to FDA
GLP regulations are found in CFR21 Part 58
Started with deaths of test animals due to excessive bleeding from warfarin
3 multiple choice options
The OECD published a series of principles of Good Laboratory Practices and Compliance Monitoring. What does not apply to the OECD and the GLP principles?
OECD stands for Organization for Economic Cooperation and Divestment
OECD sets standards for the management of testing facilities and reporting of study results
The OECD is involved with GLP regulations but does not operate under the US FDA
The shared GLP principles will help eliminate trade barriers for tested chemicals among member countries
OECD stands for Organization for Economic Cooperation and Divestment
3 multiple choice options
The main goal of pre-clinical animal testing is to determine the ______________ to use in initial clinical trials for therapeutics in healthy human volunteers.
Minimum safe starting dose
Maximum safe starting dose
Maximum effective starting dose
Minimum effective starting dose
Maximum safe starting dose
3 multiple choice options
Which of the following GLP activities is not the main responsibility of the Quality Assurance unit?
Quality assurance checks to be sure that no deviations from approved protocols were made without proper authorization and documentation
Quality assurance assigns a principal investigator for each site in multisite pre-clinical studies
Quality assurance reviews final study reports to ensure accurate listing of the protocols that were followed
Quality assurance reviews final study reports to ensure that the reported results are accurate
Quality assurance assigns a principal investigator for each site in multisite pre-clinical studies
3 multiple choice options
What is not compliant with GLP requirements regarding facilities or operation of facilities used for animal testing?
Facilities should be of suitable size and construction for proper conduct of studies
Mixing of animals used in different studies should be avoided
Animals of different species should co-mingle in the same room
Facilities should have proper separation to avoid contamination
Animals of different species should co-mingle in the same room
3 multiple choice options
What is not a GLP requirement regarding equipment in animal testing laboratories?
Protocols for use of the equipment needs to be written and followed
Equipment should be the best that the company's budget can afford
Equipment size and design should be appropriate for its use
Equipment needs to be properly cleaned, maintained, and calibrated according to schedule
Equipment should be the best that the company's budget can afford
3 multiple choice options
During pre-clinical research, a starting lead compound usually requires optimization of one or more of its properties. What is a property of a lead compound that researchers attempt to improve?
In some diseases, like certain cancers, broaden inhibition of multiple targets
Increase the drug's excretion by the body
Decrease the drug's absorption by the body
Increasing the drug's adverse health effects
In some diseases, like certain cancers, broaden inhibition of multiple targets
3 multiple choice options
What is not correct about the regulation of animal research under the Animal Welfare Act of 1966?
The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA
The Animal Welfare Act sets standards regarding the housing, feeding, cleanliness, and medical care of research animals
The Animal Welfare Act encourages replacing animals with alternative models where possible
The Animal Welfare Act states that tests and experiments should be refined to ensure the best conditions for the animals
The Animal Welfare Act is enforced by Bioresearch Monitoring Office of the FDA
3 multiple choice options
What applies to an animal facility that had been disqualified by the FDA for serious GLP violations?
Study sponsor can still use information that were generated with non-GLP compliant practices
Studies completed in the testing site may not be considered in support of application for marketing.
There are no corrective actions that a disqualified facility can take to be reinstated and allowed to operate
The facility will be forever banned from conducting animal tests
Studies completed in the testing site may not be considered in support of application for marketing.
3 multiple choice options
What is not associated with the first "clinical trial" on the effects of certain chemicals on human health?
Findings contributed to passage of the Pure Food and Drug Act of 1906
The clinical investigation was not supervised by a licensed physician
The safety of the food preservatives were not tested in animals prior to testing in humans
Led to a law which prohibited interstate transport of unapproved drugs
The clinical investigation was not supervised by a licensed physician
3 multiple choice options
What was the first law that required drug developers to demonstrate by way of clinical trials, that an investigational drug is both safe and effective in humans subjects prior to marketing approval?
Hatch-Waxman Act of 1984
Biologics Control Act of 1902
Kefauver-Harris Amendments to FFDCA in 1962
Pure Foods and Drug Act of 1906
Kefauver-Harris Amendments to FFDCA in 1962
3 multiple choice options
What is not true of an Investigational New Drug Application?
IND approval will allow legal movement of unapproved drugs between states and into the US
IND requirements are found in CFR21 Part 312
After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start
IND application is also known as FDA form 1571
After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start
3 multiple choice options
An IND is not filed to:
Inform the FDA of a change in the location of an animal testing site.
Test a drug with a previously approved active pharmaceutical ingredient but in a new dosage form
Test a drug with a previously approved active pharmaceutical ingredient but in a higher strength formulation
Test a drug with an new active pharmaceutical ingredient in phase I human clinical trials
Inform the FDA of a change in the location of an animal testing site.
3 multiple choice options
An IND submission to the FDA may not be required if:
An approved breast cancer drug will be tested for ability to treat liver cancer
A once a day, higher strength of an approved gastric efflux drug will be tested
An intravenous formulation of a drug will be tested in an oral dosage form
An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.
An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.
3 multiple choice options
An IND submission to the FDA requires information in 3 major areas. What information is not included in those 3 areas?
Study protocol for clinical testing in human subjects
Chemical description of the drug, the manufacturing process, and controls
Pre-clinical animal toxicity results
Proposed label and packaging information and design
Proposed label and packaging information and design
3 multiple choice options
An IND includes details on the plan for clinical testing. What information may not appear in the study plan for clinical testing?
Description of possible risks to subjects and strategies for protection of subjects
A science-based justification for testing in humans
Qualifications of clinical investigators
Professions of the test subjects
Professions of the test subjects
3 multiple choice options
One objective of clinical trials is to determine what the body does to the drug or pharmacokinetics. What is not part of pharmacokinetics?
If the active ingredient of the drug is being broken down in the liver to less active or even toxic forms
How effectively the drug is distributed to target cells or tissues, like a brain cancer drug effectively reaching the brain.
If the active ingredient is mostly being excreted such that the amount absorbed is not enough to be effective
How much elevation in activity in liver enzymes is observed when taking the investigational drug
How much elevation in activity in liver enzymes is observed when taking the investigational drug
3 multiple choice options
In which trial design are patients assigned to 2 treatment groups where the details of who among the patients get the investigational drug and who gets the placebo are known to the clinical investigator but not to the trial participants?
Parallel double-blind design
Randomized open design
Parallel open-label design
Parallel blinded design
Parallel blinded design
3 multiple choice options
What does not apply to the different phases of clinical trials?
In phase III trials is where the maximum tolerated dose of an investigational drug is determined
In Phase I clinical trials, the safety or toxicity of the drug is mainly tested in a small group of normally healthy individuals
A phase IV study is sometimes conducted to demonstrate possible superiority against a competitor drug
In Phase II of clinical trials, the efficacy and safety of the investigational drug is normally first tested in individuals (up to a few hundreds) who have the condition being treated.
In phase III trials is where the maximum tolerated dose of an investigational drug is determined
3 multiple choice options
CFR21 Part 50 on The Protection of Human Subjects' was written directly in response to:
World Medical Association's Declaration of Helsinki
Deformities that occurred as a result of the morning sickness drug, Thalidomide.
New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama
Death of children from the use of antifreeze ingredient used as sweetener in antibiotic sulfanilamide elixir
New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama
3 multiple choice options
What is true about ICH?
Organized to expose drug manufacturing practices that are non-compliant with regulations
GCP guidelines are covered under ICH Q6
GCP guidelines are covered under ICH E6
ICH is an organization tasked to prosecute violations of GLP regulations by drug manufacturers
GCP guidelines are covered under ICH E6
3 multiple choice options
What applies to informed consent?
Participants are prevented from being negatively influenced by family members
A process by which a subject is coerced to participate in a particular trial after being informed of all aspects of the trial
An informed consent is required even when participants are in life threatening situations
Participants are informed that their health may or may not improve as a result of participating in the trial
Participants are informed that their health may or may not improve as a result of participating in the trial
3 multiple choice options
What is not one of the principles of GCP according to ICH guidelines?
Investigators should routinely deviate from the FDA-approved clinical trial protocol
Possible benefits of trial participation must greatly outweigh the risks to a patients health
Clinical trial supplies must meet Good Manufacturing Practices standard
Clinical trial supplies must have been manufactured according to cGMP regulations
Investigators should routinely deviate from the FDA-approved clinical trial protocol
3 multiple choice options
What is not meant to be answered by conducting clinical trials?
Does the investigational drug treat, cure, or provide relief for a particular condition?
What are the harmful effects of the investigational drug on humans?
Does the investigational drug improve the skill and dexterity of investigators?
What happens to the investigational drug upon administration to humans?
Does the investigational drug improve the skill and dexterity of investigators?
3 multiple choice options
What is not true of the study protocol?
The study protocol is designed to answer specific research questions about the behavior, safety and efficacy of an investigational drug
The study protocol includes a description of the personnel and their qualifications, and trial subjects who will be involved in the clinical study
The study protocol cannot be changed at any time by trial sponsors
The study protocol allows researchers at multiple locations to perform the study in exactly the same way so that their data can be combined as though the study was done in a single site.
The study protocol cannot be changed at any time by trial sponsors
3 multiple choice options
What is not true of the trial sponsor?
The trial sponsor can be a federal agency like the Center for Disease Control (CDC) or the National Institutes of Health (NIH)
The trial sponsor is responsible for ensuring compliance with regulatory requirements, including adherence to good clinical practices
The trial sponsor takes responsibility for initiating, managing, and financing a clinical investigation
The trial sponsors are appointed by the study monitors
The trial sponsors are appointed by the study monitors
3 multiple choice options
What is not true of the Institutional Review Board?
Any change in the study protocol must have approval from IRB, except in life threatening situations
The IRB is designated by the trial sponsor to approve, monitor, and review biomedical and behavioral research protocols involving humans.
The IRB assures that the clinical trial protocol complies with regulations
The IRB assesses whether the benefit of participating in the trial outweighs the possible risks to the health of trial subjects
The IRB is designated by the trial sponsor to approve, monitor, and review biomedical and behavioral research protocols involving humans.
3 multiple choice options
_______________ is a document given by the investigator to the sponsor to provide the sponsor with information about the qualifications of the PI, and at the same time remind the PI of his or her regulatory responsibilities.
Statement of Investigator
FDA form 1570
Investigator's Brochure
FDA Form 483
Statement of Investigator
3 multiple choice options
Under the FDA's Bioresearch Monitoring Program, if a clinical trial investigator receives an official action indicated after an inspection and chooses to ignore it, he will be issued a warning letter. What is not true of an OAI?
With an OAI, FDA requires a response from the investigator within 15 days
An OAI is the least common outcome of an FDA's inspection of a clinical trial site
An OAI may result to disqualification of an investigator from participation in any future clinical research
An OAI is issued after inspection when minor violations are observed
An OAI is issued after inspection when minor violations are observed
3 multiple choice options
Jesse Gelsinger was a clinical trial participant in one of the first clinical trials on an investigational gene therapy approached approach that tested adenovirus as a vector to introduce a functional gene to replace a defective gene. He died as a result of a massive immune response to the AAV. What is not a GCP violation that the investigators involved were found to have committed?
The principal investigator assigned to the trial employed unqualified and improperly trained staff
Jesse had a health condition that should have excluded him from participating in the trial
There were conflict of interests, i.e., scientists and the hospital were getting research funding from the company sponsoring the trial
Trial participants were not completely informed of deaths of monkeys in pre-clinical studies
The principal investigator assigned to the trial employed unqualified and improperly trained staff
3 multiple choice options
FDA will not impose a clinical hold on a trial if:
The FDA has questions about the quality or sterility of the investigational drug based on information in the chemistry, manufacturing and controls portion of the IND submission
While the trial is being conducted, unreasonable adverse health effects on patients started to show up
The trial sponsor has not paid the required PDUFA fee
The FDA finds that the study protocol or design proposed in the IND submission does not provide sufficient assurance that risks to the of health study participant would be minimized
The trial sponsor has not paid the required PDUFA fee
3 multiple choice options
Of about 5000 drugs that companies investigate as a drug candidate, only 1 will successfully make it to market. What is the top cause of drug failure?
Unfavorable pharmacokinetics
The new drug will not be able to compete successfully with the earlier marketed drug
The test drug has unacceptable adverse effects in human trials
The investigational drug exhibited unacceptable toxicity to test animals
Unfavorable pharmacokinetics
3 multiple choice options
The Common Technical Document:
Is provided to clinical trial investigators in US, EU or Japan, to provide data and information about the investigational drug to be tested
Contains data and information submitted as part of a requirement prior to field testing of crops engineered to produce novel proteins
Contains data and information provided to clinical investigators in US, EU or Japan to guide the conduct of a clinical trial
Contains data and information submitted as part of marketing applications for a pharmaceutical for human use for US, EU or Japan.
Contains data and information submitted as part of marketing applications for a pharmaceutical for human use for US, EU or Japan.
3 multiple choice options
In which type of marketing application would it be typical for the FDA to require efficacy data for a marketed drug being submitted for use in a new indication, and not require additional safety data?
Supplemental New Drug Application
Over-the-counter drug application
Abbreviated new drug application
Biologics license application
Supplemental New Drug Application
3 multiple choice options
What type of information is not contained in a New Drug Application (NDA) which is submitted to the FDA?
The NDA should provide evidence that methods used in manufacturing assured the drug's quality
The NDA should prove that the drug's proposed labeling (package insert) is accurate and informative
The NDA should provide evidence that the drug is safe and effective in its proposed use(s)
The NDA should provide evidence that there are no alternatives to the use of primates in safety tests
The NDA should provide evidence that there are no alternatives to the use of primates in safety tests
3 multiple choice options
New Drug Applications (NDA) have chemistry, manufacturing and controls (CMC) section that tells the whole story about the candidate drug. Which type of information is included in the CMC?
Evidence that there is a substantial pool of patients that is in need of the new drug
Evidence that the clinical trial protocol was designed to minimize risks to trial participants
The ingredients or components of the drug product
Evidence that there are no alternatives to the use of primates in safety tests
The ingredients or components of the drug product
3 multiple choice options
When is a complete response letter (CRL) issued by the FDA in response to a drug marketing application?
A CRL is issued if the drug failed to demonstrate effectiveness in human clinical trials
A CRL is issued if there were no safety issues observed during the clinical trials
A CRL is issued if the clinical trial plan in a proposed IND is unacceptable
A CRL is issued if the required prescription drug user fee has not been paid
A CRL is issued if the drug failed to demonstrate effectiveness in human clinical trials
3 multiple choice options
What is not correct about patents and marketing exclusivity?
Marketing exclusivity is granted by the USPTO upon drug approval to protect the drug from generic competition
Patents are granted by the USPTO and expire 20 years from date of filing
Orphan drug designation adds 7 years of market exclusivity from generic competition
Marketing exclusivity can extend protection from generic competition beyond the patent life.
Marketing exclusivity is granted by the USPTO upon drug approval to protect the drug from generic competition
3 multiple choice options
A __________ is granted by FDA to market an unapproved drug when there is an infectious disease that poses a serious threat to public health and when there is no currently formally approved drug for treatment of the disease
Emergency Use Amendment
Emergency Use Administration
Emergency Use Approval
Emergency Use Authorization
Emergency Use Authorization
3 multiple choice options
What is not true of cGMP?
The phrase "Good Manufacturing Practices" first appeared in the Food, Drug, and Cosmetic Act of 1938, to set tolerances for toxic ingredients in drugs, such as cocaine, heroine, alcohol and morphine
cGMP requires documentation of process performance and product quality through accurate and complete written records
cGMP stands for current Good Manufacturing Practices
cGMP is required for drugs manufactured for use in pre-clinical testing
cGMP is required for drugs manufactured for use in pre-clinical testing
3 multiple choice options
cGMPs are regulations that govern the manufacture of food, drugs, biologics, and medical devices to assure the quality, identity, purity and strength (QuIPS) of the finished product consistently over the life of the product. What quality attribute of a drug product, like vitamins or antibiotics, is expressed in activity or international units (IU)?
Strength
Stability
Identity
Purity
Strength
3 multiple choice options
Under the Kefauver-Harris amendments of the Federal Food Drugs and Cosmetic Act (FFDCA), if the methods used in, or the facilities or controls used for, the manufacture, processing, packaging, or holding, of the drug product do not conform to cGMP, the adulterated drug as well as the _______________________ shall be subject to regulatory action.
FDA investigators
Trial sponsor
Principal investigator
Person responsible for non-compliance
Person responsible for non-compliance
3 multiple choice options
Component refers to any ingredient used in the manufacture of a drug product, including those that may no longer be detectable in the marketed drug product.
TRUE
FALSE
TRUE
1 multiple choice option
In drug manufacturing, what does not apply to the batch number?
The batch number consists of a combination of letter(s) and numbers
The batch number is the total number of units produced in a single manufacturing run
The batch number facilitates recall of a batch of drugs found with quality issues
The batch number is useful in knowing the history of the manufacture, packing, holding and distribution of a drug product
The batch number is the total number of units produced in a single manufacturing run
3 multiple choice options
ICHQ7A are guidances observed for the manufacture of ________________, while FDAs cGMPs in CFR21 part 211 are regulations that mainly cover the manufacture of _______________.
Active Pharmaceutical Ingredients:Finished drug pharmaceuticals
Biologics: Pharmaceutical drugs
Generic drugs: Biologics
Finished drug products: Active Pharmaceutical Ingredients
Active Pharmaceutical Ingredients:Finished drug pharmaceuticals
3 multiple choice options
What is not true of phase III drug manufacturing activities?
During phase III is usually when a company puts drug products in a stability program to determine how product quality deteriorates or is preserved with time
During phase III is when lead optimization is finalized
During Phase III, the company prepares extensively for FDA's pre-approval inspection
During phase III, company demonstrates that they are able to manufacture 3 lots of drug products that meet quality specifications
During phase III is when lead optimization is finalized
3 multiple choice options
cGMP requires the establishment of a quality system and the designation of an independent quality unit to oversee the quality system. The quality control unit is not responsible for the approval and release of:
the company's quarterly financial reports
raw materials and in-process materials
components, containers, and closures
packaging and labeling materials
the company's quarterly financial reports
3 multiple choice options
From the Amgen video, what is the main reason as to why personnel wear full body gowns or suits before entering a sterile drug production suite?
Prevent the inhalation of microbial aerosols
Protect the workers from dust
Prevent contamination of the drug
Protect the workers from toxic fumes
Prevent contamination of the drug
3 multiple choice options
Which of the following CFR21 part 211 regulations is not found under subpart B on organization and personnel?
Personnel should wear apparel appropriate to protect product from contamination
Personnel should not eat while working on the manufacturing floor
There must be controlled personnel access to certain limited-access areas
Personnel must have education, cGMP training, and experience to perform the assigned functions
Personnel should not eat while working on the manufacturing floor
3 multiple choice options
What is not part of cGMP regulations concerning buildings and facilities?
The washing and toilet facilities should be very far from the manufacturing suites
Cleaning should be performed according to procedures and as scheduled
There should be good product flow starting from the raw material receiving, to manufacturing, and to distribution of drug products.
The facility should be of sufficient size to allow separation of different manufacturing activities
The washing and toilet facilities should be very far from the manufacturing suites
3 multiple choice options
For a New Drug Application (NDA) filing, the FDA requires at least _________ lots, or batches, of the drug product to be manufactured with consistent quality and evaluated in a stability program.
3 lots
2 lots
5 lots
1 lot
3 lots
3 multiple choice options
What is not a cGMP requirement for equipment?
Equipment should be cleaned as scheduled according to pre-written procedures
The effect of a replacement part on the quality of the product should be evaluated before implementation
Equipment should be highly reactive with the product
Only food-grade lubricants or oils should be used for maintaining equipment
Equipment should be highly reactive with the product
3 multiple choice options
Under equipment cGMP regulations, what is an example of how computer systems would be considered as deficient in controls that are needed to assure consistent operation?
All laboratory analysts share the same password for the computer which runs the AKTA which is used for protein separation
Requalification of equipment was performed because a new software was installed
All files and data are backed up in case of system malfunction
Operations are performed by one person and double-checked by another
All laboratory analysts share the same password for the computer which runs the AKTA which is used for protein separation
3 multiple choice options
There are four phases in biotherapeutic protein production described in the Roche video. Which is not one of the four?
The recombinant DNA construct is transformed into E. coli
Fermentation of cells in bioreactors at manufacturing scale
Cells are separated from the nutrient solution by centrifugation and filtration
Cultivation starts from frozen animal cells
The recombinant DNA construct is transformed into E. coli
3 multiple choice options
What is not true of regulations concerning the control of components, containers, and closures?
Procedures on the receipt, identification, storage and handling of components, containers, and closures should be verbally communicated all the time
Components, containers, and closures are to be stored off the floor (in pallets) in the manufacturing site
Upon receipt, components, containers, and closures are quarantined prior to testing and release by the Quality control group
Upon receiving, components, containers, and closures are to be inspected for correctness of labels, contents, container damage or broken seals, and contamination.
Procedures on the receipt, identification, storage and handling of components, containers, and closures should be verbally communicated all the time
3 multiple choice options
What property of containers and closures will compromise the quality of drug products?
Containers and closures should be minimally reactive with the drug product
Containers and closures should not absorb any of the drug components
Container and closures should readily allow the loss of the drug material to the outside
Containers and closures should be free of endotoxins from gram-negative bacteria that will cause fevers when injected into a patient's bloodstream
Container and closures should readily allow the loss of the drug material to the outside
3 multiple choice options
When a raw material (or component) passes specifications, it is ready to be charged into and used in the manufacturing process. Usually a portion of the bulk material is transferred into a properly labelled container. What information is not to be found on the container label?
Weight of the component
Date of FDA approval
Product batch for which the raw material is being dispensed for
Signatures of who weighed the component and who cross-checked the information
Date of FDA approval
3 multiple choice options
For the sampling of components, containers, and closures, there should be a written protocol that needs to be followed. What is not compliant with cGMPs for the sampling procedures and tests?
There should be a pre-determined criteria for acceptance or rejection of the materials
Samples should be taken at representative and random places in the beginning, middle and end for each material
FDA requires at least 1 test of conformity to specifications as to CC quality and identity
During sampling, steps should be taken to expose components, containers, and closures to the air for long durations so they can get aerated
During sampling, steps should be taken to expose components, containers, and closures to the air for long durations so they can get aerated
3 multiple choice options
For a tablet drug dosage form, what would not be considered a critical quality attribute?
Disintegration time
Tablet to tablet uniformity of API amounts
Presence of floating fibers
Tablet to tablet weight variation
Presence of floating fibers
3 multiple choice options
What is meant by bioburden?
The microbial counts on a drug component or in-process materials
The microbial contamination on the personnel's skin
The burden on a biotech company's revenue as a result of aborted drug development
The level of health risks that a patient is exposed to when taking the drug
The microbial counts on a drug component or in-process materials
3 multiple choice options
Many production SOPs have time limitations on the performance of a process. What would not be a cGMP-related reason as to the need for time limitation?
Prolonged holding of a raw material can increase risks of microbial contamination
Insufficient drying can lead to unacceptable moisture levels in tablets
Prolonged process can lead to longer working hours
Insufficient mixing may lead to failed content uniformity in tablets
Prolonged process can lead to longer working hours
3 multiple choice options
Which is not true about cGMP regulations on packaging and label control?
Labels should be examined for conformity with information in batch production records
Labels for different drug products should be segregated
Excess labels issued should be returned to the company that printed them
Batch or lot numbers should be included in labels to facilitate tracking in case of customer complaints about the drug products or for recalls
Excess labels issued should be returned to the company that printed them
3 multiple choice options
The _____________________ on drug product labels is based on stability tests and can be affected by storage conditions, the most important of which are humidity and temperature.
Indication
Strength
Expiration date
Conditions for safe use
Expiration date
3 multiple choice options
Under CFR21, Subpart I on laboratory controls, what is not correct about cGMP requirements for release testing of drug products?
Release test methods should be accurate, sensitive, specific, and reproducible
Tests should be performed to determine conformance to specifications prior to the release of each batch
Microbiological tests should be performed for all types of drug products prior to release for marketing
Conformance testing should be performed by the quality control unit
Microbiological tests should be performed for all types of drug products prior to release for marketing
3 multiple choice options